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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Primary
510(k) Number K844235
Device Name CHLORIDE STANDARD
Applicant
Shaban Mfg. Co.
3052 Metro Pkwy.
Fort Myers,  FL  33901
Applicant Contact BARBARA H SNEADE
Correspondent
Shaban Mfg. Co.
3052 Metro Pkwy.
Fort Myers,  FL  33901
Correspondent Contact BARBARA H SNEADE
Regulation Number862.1150
Classification Product Code
JIS  
Date Received11/01/1984
Decision Date 11/20/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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